In brief: patent prosecution in India (2024)

Scope and ownership of patents

Types of protectable inventions

Can a patent be obtained to cover any type of invention, including software, business methods and medical procedures?

Although section 2(1)(j) of the Patents Act states that any new product or process involving an inventive step that has an industrial application is patentable, Chapter 2, sections 3 and 4, of the Act define inventions that are not patentable.

Section 3

Non-patentable inventions defined in section 3 include the following:

• an invention that is frivolous or that is contrary to well-established laws;
• an invention of which the primary or intended use or commercial exploitation would be contrary to public policy or morality or that would cause serious prejudice to human, animal or plant life or health, or to the environment;
• the mere discovery of a scientific principle or the formulation of an abstract theory or the discovery of any living or non-living substance occurring in nature;
• the mere discovery of a new form of a known substance that does not result in the enhancement of the known efficacy of that substance or the mere discovery of any new property or new use for a known substance or of the mere use of a known process, machine or apparatus unless such known process results in a new product or employs at least one new reactant (according to the explanation to this clause, ‘salts, esters, ethers, polymorphs, metabolites, pure form, particle size, isomers, mixtures of isomers, complexes, combinations and other derivatives of known substances shall be considered to be the same substance, unless they differ significantly in properties with regard to efficacy’);
• a substance obtained by a mere admixture resulting only in the aggregation of the properties of the components thereof or a process for producing such substance;
• the mere arrangement or rearrangement or duplication of known devices, each functioning independently of another in a known way;
• a method of agriculture or horticulture;
• any process for medical, surgical, curative, prophylactic, diagnostic, therapeutic or other treatment of human beings or any process for a similar treatment of animals to keep them free of disease or to increase their economic value or that of their product;
• plants and animals in whole or any part thereof other than micro-organisms but including seeds, varieties and species and essentially biological processes for the production or propagation of plants and animals;
• a mathematical or business method or a computer program per se or algorithms;
• a literary, dramatic, musical or artistic work or any other aesthetic creation, including cinematographic works and television productions;
• a mere scheme or rule or method of performing mental acts or method of playing games;
• a presentation of information;
• topography of integrated circuits; and
• an invention that, in effect, is traditional knowledge or that is an aggregation or duplication of known properties of a traditionally known component or components.

Section 3(c) – Natural non-living substances

The Madras High Court, in Genmab A/S v Assistant Controller of Patents and Designs, 2024:MHC:1149, dated 6 March 2024, and Imclone LLC v Assistant Controller of Patents and Designs, (T) CMA (PT) No. 126 of 2023, dated 6 March 2024, held that non-living substances occurring in nature or that are isolated from nature are not eligible for patents, but a synthetic version of a rarely occurring substance, crucial for treating illness when produced in large quantities, would not be excluded if other criteria, such as novelty and technical advance, were satisfied.

Section 3(d) – New forms of known substances

In DS Biopharma Limited v The Controller of Patents and Designs and Anr in CA (COMM.IP-PAT) 6/2021 [2022:DHC:3563], the Delhi High Court held that the identification of a known substance was a pre-requisite for the application of section 3(d).

As per section 3(d), a new form of a known substance is not patentable. In Abbvie Inc v Deputy Controller of Patents & Designs [2023:MHC:5451], dated 20 December 2023, the Court discussed section 3(d). The subject matter of the patent in the case relates to the polymorphic forms of a parent compound. This compound only became public knowledge after the priority date of the claimed patent of the polymorphic form. Therefore the Court held that as polymorphic forms are not forms of a known substance, section 3(d) did not apply.

Section 3(i) – Diagnostic methods and methods of treatment

The Madras High Court, in The Chinese University of Hong Kong & Ors v The Assistant Controller of Patents, and Designs [2023:MHC:4617], dated 12 October 2023, held that if a screening test that preliminary identifies a condition subject to confirmation by definitive tests, still qualifies as diagnostic method under section 3(i) of the Patents Act.

The Court observed that the word ‘diagnostic’ should be limited to diagnostic processes that disclose pathology for the treatment of human beings only, but that should not be limited to only in vivo methods, as the Patents Act does not explicitly refer to this.

Further, the Court suggested that the determinative question to analyse a diagnostic method is to check if the test is inherently capable of identifying the disease, disorder or condition to be treated in a person by itself. The question’s scope should not be unduly curtailed by limiting it to in vivo or definitive diagnoses. Thus, in October 2023, the Court held that the determination of foetal fraction is related to diagnosis but is not ‘diagnostic’, as per section 3(i). The Court allowed the patent application to proceed to grant, and suggested amending the law restricting the scope of the expression ‘diagnostic’ in section 3(i) to in vivo processes.

The Court further held that neither a definitive nor comprehensive diagnosis is a prerequisite for a test to qualify as ‘diagnostic’ under section 3(i) of the Patents Act.

In The Delhi High Court in Arthrogen Gmbh v Controller General of Patents, Designs and Trademarks, dated 5 February 2024, the Court held that the claims of the patent in question were related to a method of producing a protein-enriched blood serum that results in a composition (ie, a protein-enriched blood serum). The Court also held that the potential use of the produced serum could be hom*ologous blood transfusion, but this would form an application of the product and not the claimed invention itself. Thus, the Court held that the invention only claims a method of producing a specific substance and is not related to a method of treatment – a significant distinction that affects its patentability. Accordingly, the Court held that said method did not qualify as a method of treatment under section 3(i).

Section 3(k) – Software and business methods

The Madras High Court’s decision in Priya Randolph & Ors v Deputy Controller of Patents, and Designs [2023:MHC:5450], dated 20 December 2023, held that a claim would qualify as being only business method if the claim is in substance a business method.

The Delhi High Court, in Microsoft Corporation v The Assistant Controller of Patents, and Designs [2023:DHC:2331], dated 27 March 2023, held that the Patent Office must take into account the judgment in Ferid Allani v Union of India and Ors, in that the technical effect or contribution has to be considered while assessing patents under section 3(k).

The Delhi High Court, in Raytheon Company v Controller of Patents, and Designs [2023:DHC:6673], dated 15 September 2023, emphasised that it is well-settled law that a hardware requirement is not to be insisted upon in applications related to computer programs, as such a requirement is a higher standard that lacks any basis in law. The Court further held that when examining computer-related applications under section 3(k), the settled law is provided in Ferid Allani v Union of India and Orsand Microsoft Corporation v The Assistant Controller of Patents, and Designs.

Section 4 – Atomic energy

Section 4 includes inventions relating to atomic energy. In 2016, in a decision given by the Kolkata Patent Office, a patent application by Merck Eprova AG was refused for falling within the ambit of section 4 (relating to the field of atomic energy as prescribed by section 20 of the Atomic Energy Act) of the Patents Act. The Controller of Patents refused the application based on a letter from the Department of Atomic Energy, which stated that the invention relates to atomic energy and should be refused.

The courts have ruled that orders rejecting a patent application because it falls under the ambit of section 4 must include the reasons for the rejection. The following decisions rejecting such applications have been set aside:

• decision of the Bombay High Court, dated 6 October 2022, Ceres Intellectual Property Company Limited v The Controller of Patents, Trademarks and Designs & Ors [WO2257/2018); and
• the decision of the Delhi High Court, dated 4 April 2016, in ER Squibb & Sons, LLC v UOI [WP(C) 2879/2016].

In ER Squibb & Sons, the Court also held that the petitioner should be allowed to file representation with the Department of Atomic Energy.

Patent ownership

Who owns the patent on an invention made by a company employee, an independent contractor, multiple inventors or a joint venture? How is patent ownership officially recorded and transferred?

A company employee or an independent contractor’s right to apply for and own a patent is governed by the terms of the agreement between the employee and employer or the contractor and the contracting party.

A patent may be owned by an individual, a group of individuals or a legal entity (eg, a company). A firm may also apply for a patent as an assignee (Shinning Industries v Shri Krishna Industries, AIR 1975 ALL 231).

A patent may be jointly filed and owned by two or more parties. An application may be filed by the inventor or assignee, or a legal representative of deceased persons who were entitled to make such an application, immediately before their death. A patent applicant may be a legal entity and need not necessarily be a natural person.

In the case of jointly owned rights in a patent, unless there is an agreement to the contrary, each of the co-owners shall exercise his or her rights to his or her own benefit without accounting to the other owners. A licence under the patent shall not be granted and a share in the patent shall not be assigned by a co-owner without the consent of the other co-owners (section 50 of the Patents Act).

The rights in the invention can be assigned to any person or legal entity either during the pendency of the application or after the patent is granted. Section 68 of the Patents Act states that assignment, mortgage, licence or creation of any other interest in the patent shall not be valid unless it is in writing, outlining the terms and conditions governing the rights and obligations of each party.

Where persons become entitled by assignment, transmission or operation of law to a patent or to a share in a patent, they have to apply to the controller for the registration of their title in the register of patents (section 69 of the Patents Act).

The Patent Office maintains a register wherein all information pertaining to a patent, including names and addresses of the grantees, their assignees, notifications of such assignments and of transmissions of patents, licences under patents and amendments, extension and revocation of patents, is recorded (section 67 of the Patents Act).

In Order No. 252 of 2013 in NTT DoCoMo Inc v Controller of Patents, the Intellectual Property Appellate Board (IPAB) clearly held that the applicant for a patent has to substantiate or establish the proof of right to make an application irrespective of the nature of the application, namely, convention, non-convention, national phase or a divisional application.

Section 7 of the Patents Act, read with Rule 10 of the Patent Rules 2003, requires an applicant to submit ‘proof of right’ for the filing of the application. The applicant can file a Form 1 executed by the inventors or a worldwide assignment, confirmatory assignment or employment contract, etc. The IPAB in Dow Agrosciences LLC vs Controller of Patents (order dated 17 October 2021, OA/63/2020/PT/DEL) concluded that the legal requirement of filing the proof of right is met by filing a declaration under Rule 4.17(ii) in respect of national phase applications.

In NEC Corporation v The Assistant Controller of Patents and Designs [CMA(PT)/29/2023], dated 19 December 2023, the Madras High Court found the declaration submitted by the applicant regarding the company’s employment of the patent’s inventors was permitted as a valid proof of right document, as the assignment and inventor’s declaration were on record with the United States Patent and Trademark Office. The Court also said that in such matters, there is a distinction between the date of assignment and the date of declaration.

Patent office proceedings

Patenting timetable and costs

How long does it typically take, and how much does it typically cost, to obtain a patent?

In the year 2023-2024, the disposal of patent applications was speedy. For the first time, the Patent Office issued more than 100,000 grants. The period for granting a patent is two to three years.

A revised fee structure has been provided for the filing of a patent application as well as other proceedings before the Patent Office by the recently amended Patent Rules. A third category of applicant for patents has been introduced in the form of ‘small entity’, and the fees charged to them have been fixed in between the fees for a natural person and all persons other than natural persons (except a small entity). The amended rules also provide for a 10 per cent additional fee when the applications for patents and other documents are filed through the physical mode, ie, in hard copy format as opposed to the online mode.

The Department for Promotion of Industry and Internal Trade, under the Ministry of Commerce and Industry, introduced the Patents (Amendment) Rules 2021on 21 September 2021.

The 2021 amendments provide reduced fees for educational institutions. It defines an ’educational institution’ as a university established or incorporated under or by a central act, a provincial act or a state act, and includes any other educational institution as recognised by an authority designated by the central government or the state government or the union territories in this regard.

The amendments provide that in the case of a small entity, a start-up or an educational institution, every document for which a fee has been specified shall be accompanied by form 28. The rules also provided a revised form 28.

The Rules also provide that when an application processed by a natural person, a start-up, a small entity or an educational institution is fully or partly transferred to a person, other than a natural person, a start-up, a small entity or an educational institution, the difference, if any, in the scale of fees between those charged to a natural person, a start-up, a small entity or an educational institution and those chargeable from the person other than a natural person, a start-up, a small entity or an educational institution shall be paid by the new applicant along with the transfer request.

The Department for Promotion of Industry and Internal Trade under the Ministry of Commerce and Industry introduced the Patents (Amendment) Rules 2024 on 15 March 2024. The 2024 Rules brought out the following changes:

• The timeline for completing form 3 has changed. The applicant is required to file form 3:
  • within six months from the date of filing;
  • within three months from the date of the first examination report was issued;
  • two months from the date of communication by the Controller under section 8(2).
• In view of the decision of the Divisional Bench of the Delhi High Court in Syngenta Limited v Controller of Patents and Designs [2023:DHC:7473-DB], Rule 13 was revised to incorporate a sub-rule (2A), allowing the applicant to file a divisional application from the subject matter of the specification.
• Working statements in form 27 are now required to be submitted every three financial years, as opposed to the existing requirement of submitting working statements every year.
• The time period for filing an extension request under Rule 138 has been revised so that such requests can be filed before the expiry of a six-month period. A delay may be condoned for a maximum period of six months.

Expedited patent prosecution

Are there any procedures to expedite patent prosecution?

The Patent Office is in the process of modernising and expanding and has recruited a large number of examiners. This is expected to reduce the period for the grant of a patent from about five to seven years to an average of two to five years.

The application is published after the expiry of 18 months from the date of filing or priority date, whichever is earlier. The publication of the application can be accelerated by filing a request to the Controller with the requisite fee.

The Patents Rules 2003 were amended in 2016 and have been effective since 16 May 2016. The new Rules brought major procedural changes in patent prosecution for expediting the prosecution of patent applications, some of which are as follows.

• Examination of applications: the reply to the examination report has to be filed within six months (instead of 12 months) from the date of issuance of the first statement of objections. This period can be extended by three months provided the request for extension is filed before the expiry of a six month period.
• Expedited examinations of application provisions are available.
• Hearings: hearing submissions have to be filed within 15 days of the date of the hearing. A hearing adjournment request should be made at least three days before the date of the hearing. No party will be given more than two adjournments and each adjournment shall not be for more than 30 days.

The Department of Promotion of Industry and Internal Trade, under the Ministry of Commerce and Industry, published the Patent (Amendment) Rules 2019, which came into force on 17 September 2019. The Rules were amended to expand the eligibility criteria for expedited examination.

Expedited examinations were previously available for applicants who had selected India as an international searching authority or as an international preliminary examining authority (IPEA) in the corresponding international application, or if the applicant is a start-up. The definition has been expanded to also include applications from the following:

• small entities;
• natural persons, or in the case of joint applicants, where all the applicants are natural persons, if the applicant or at least one of the applicants is female;
• a government department;
• an institution established by a central, provincial or state act, which is owned or controlled by the government;
• a government company as defined in clause 45, section 2 of the Companies Act 2013 (18 of 2013);
• an institution wholly or substantially financed by the government;
• an applicant whose application pertains to a sector that is notified by the central government on the basis of a request from the head of a department of the central government; and
• an applicant whose application is eligible under an arrangement for processing a patent application pursuant to an agreement between the Indian Patent Office and a foreign patent office, and in this regard the patentability of patent applications filed under this clause will be in accordance with the relevant provisions of the Act.

As mentioned above, the Patent Office has in the last few months made a speedy disposal of patent applications. In the year 2023-2024, the Patent Office has crossed the mark of granting 100,000 patents.

Patent application contents

What must be disclosed or described about the invention in a patent application? Are there any particular guidelines that should be followed or pitfalls to avoid in deciding what to include in the application?

Under section 10 of the Patents Act, every complete specification should fully and particularly describe the invention and its operation or use and the method by which it is to be performed. It should also disclose the best method of performing the invention that is known to the applicant and for which he or she is entitled to claim protection.

The specification should end with a claim or claims defining the scope of the invention for which protection is claimed and be accompanied by an abstract to provide technical information on the invention.

With regard to the disclosure of prior art under section 10(4) of the Patents Act in the patent specification, the Patent Office and the Intellectual Property Appellate Board (IPAB) in the Novartis case recognised that under section 10(4), disclosure of prior art is not mandatory, but held that, despite there not being any specific provision under Indian law, the relevant prior art, including the closest one, ought to be disclosed in the patent specification, and the applicant cannot be considered to have discharged his or her duty or obligation unless the prior art is disclosed so that the invention can be sufficiently distinguished over the prior art.

Plausibility is an important aspect to be taken into account while drafting patent applications.

Post-filing data to demonstrate technical effects is admissible, provided the technical effect has a basis in the specification as filed. In other words, the seed of that nature must be in the specification on its priority date.

This has been held in AstraZeneca AB and Ors v Intas Pharmaceuticals Limited and Ors [2020:DHC:3125].

The High Court of Delhi reiterated AstraZeneca in Ischemix LLC v The Controller of Patents, [2023:DHC:8496]. Further, the court held that the exception to AstraZeneca is ongoing clinical trials of a known substance’s new form at the date the application was filed. Clinical trial data can be submitted to only support the stand of the applicant in the specification to demonstrate enhanced efficacy.

Therefore, it is advisable to incorporate all the data available for all possible embodiments of the invention in the specification at the time of filing the application, especially in pharmaceutical applications.

Prior art disclosure obligations

Must an inventor disclose prior art to the patent office examiner?

The Patents Act contains no provision that makes it mandatory for an inventor to disclose prior art, although to meet the requirement of sufficiency of description, it is important to distinguish the invention over the prior art, as was also held by the IPAB in Novartis v Ranbaxy and Others.

It is mandatory to provide information of the corresponding applications filed in other countries under section 8 of the Patents Act within six months of their filing, and to provide search and examination reports in the corresponding application to the Patent Office examiner. Failure to do so is a ground for pre-grant opposition, post-grant opposition and revocation of the patent. Patents have been revoked by the IPAB on grounds of non-compliance with obligations under section 8 (Uniroyal v VRC Ltd, Hindustan Unilever v Tata Chemicals, etc).

In recent years, an order by the division bench of the High Court of Delhi (DHC) has helped elucidate the legislative intent behind section 8 of the Patents Act. The division bench held that:

• the power to revoke a patent under section 64(1) is discretionary and not automatic;
• the court is to first examine whether omission to furnish information is deliberate, intentional, accidental, clerical or on account of bona fide error;
• the court will have to examine the evidence for wilful suppression of information and cannot revoke a patent immediately on the grounds of non-compliance with section 8; and
• it will also have to be determined if the omission of the information or part of the information was material to the grant of the patent, which can be answered only at the conclusion of the trial.

Pursuit of additional claims

May a patent applicant file one or more later applications to pursue additional claims to an invention disclosed in its earlier-filed application? If so, what are the applicable requirements or limitations?

A patent applicant can file either a divisional application under section 16 of the Patents Act or a patent of addition under section 54 to pursue additional claims. There is no limitation on the number of claims; however, the fee for each claim above 10 is US$20 or US$5 per claim.

The divisional application must be filed any time prior to the grant of a patent on the ground of unity of invention, and a patent of addition can be filed any time during the life of the main patent.

The IPAB has recently, in its judgment in LG Electronics Inc v Controller of Patents, adjudicated on the maintainability of divisional applications under section 16 of the Patents Act. In the order, the IPAB held the following with respect to the voluntary filing of divisional applications:

• the applicant can file one or more divisional applications if the invention disclosed in the parent application does not relate to a single invention or to a group of inventions forming a single inventive concept; and
• the divisional application should not include any claim already claimed in the parent application (to avoid double patenting).

In a decision dated 17 July 2013, in the matter of Patent Application No. 3273/KOLNP/2008 of Genentech Inc, the Controller held that the application of a divisional would be considered to be a divisional of the original parent application, provided that the divisional application is filed during the pendency of the original application.

In a recent judgment of the Divisional Bench of the Delhi High Court in Syngenta Limited v. Controller of Patents and Designs [2023:DHC:7473-DB]the court held that a divisional application filed for a subject matter which is distinct/lacks unity of invention, is maintainable for a subject matter which finds support in the specification of parent application but not in the claims of the parent application. The change is adopted by the Patent Office vide Patent [Amendment Rules] 2024.

Patent office appeals

Is it possible to appeal an adverse decision by the patent office in a court of law?

It is possible to appeal an adverse decision by the Patent Office. Under the Patents Act, an appeal against an order or directions of the Controller is heard before the High Court.

The Patents Act, section 117A, provides provisions to appeal the adverse decisions under the following sections of the Patents Act:

• sections 15 to 20;
• section 25(4);
• section 28;
• section 51;
• section 54;
• section 57;
• sections 60 and 61;
• section 63;
• section 66;
• section 69(3);
• section 78;
• section 84(1) to (5);
• section 85;
• section 88;
• sections 91 and 92; and
• section 94.

Although the Patents Act does not provide for an appeal against the order of the Controller in pre-grant opposition proceedings, a recent decision of the Delhi High Court held that an applicant is entitled to file an appeal against the order of the Controller in pre-grant opposition proceedings. As an order under section 25(1), it is to be treated as being an order under section 15 of the Patents Act, under which an order is appealable.

In two landmark cases, the IPAB treated orders issued under non-appealable provisions of sections 11(B)(4) and section 77(1)(f) of the Patents Act as appealable.

The first such order was issued under section 11(B)(4), treating an application for a patent as ‘deemed withdrawn’ for failure to file the request for examination within the prescribed period of 48 months from the date of priority of the application. Statutorily, orders passed under section 11(B)(4) are not appealable, but the appellant’s attorneys argued that since the applicant had filed the request for examination in a timely fashion, the order should be taken as an order under section 15 of the Patents Act, which bestows upon the applicant a right to appeal. The IPAB agreed with the submissions of the appellant and allowed the appeal.

In the second case, an order issued in a pre-grant opposition, which was treated as a review petition under orders of the Delhi High Court to correct a procedural irregularity that had ensued owing to a patent being granted without the processing of a pre-grant opposition, was treated as appealable by the IPAB. The IPAB held that the order issued in the review petition under section 77(1)(f) was in effect an order in a pre-grant opposition that was being treated as a review petition under directions of the high court, and that, since orders in pre-grant oppositions are appealable, the order in this case was also held to be appealable.

Oppositions or protests to patents

Does the patent office provide any mechanism for opposing the grant of a patent?

The Patents Act provides for pre-grant opposition and post-grant opposition.

After the patent application has been published in the official journal, and at any time before the grant of a patent, any person may submit a written opposition to the Controller on the grounds listed in section 25(1) of the Patents Act.

Post-grant opposition can be filed by any interested person under section 25(2) up to one year from the date of publication of the patent’s grant.

The grounds of pre-grant opposition and post-grant opposition are similar.

Priority of invention

Does the patent office provide any mechanism for resolving priority disputes between different applicants for the same invention? What factors determine who has priority?

Section 11 of the Patents Act contains the rules for fixing the priority dates. Different priority dates may be allotted to separate claims to settle disputes between different applicants for the same invention.

Modification and re-examination of patents

Does the patent office provide procedures for modifying, re-examining or revoking a patent? May a court amend the patent claims during a lawsuit?

A patent application may be amended by filing an amendment application to the Controller before or after the grant of the application, insofar as the amendment is within the scope of the disclosure, by way of disclaimer, explanation or correction. An amendment may also be effected for change of name, address, nationality or address for service (section 58 of the Patents Act, subject to section 59).

The high court, in any proceedings before it for revocation of a patent, allows patentees to amend their complete specification, subject to the terms regarding costs, among other things. Further, instead of revoking a patent, the high court can allow the specification to be amended.

The nature of amendments that are permissible to the complete specification:

• are those by way of disclaimer, correction or explanation;
• must be for the purpose of correcting an obvious mistake;
• should not claim or describe matter not disclosed in substance in the specification before amendments; and
• should fall wholly within the scope of the specification before the amendment.

In the matter of Allergen Inc v The Controller of Patents [2023/DHC/000515], it was held that the expression ‘scope of the claims’ in the Patents Act, section 59(1), requires that the complete specification be taken into consideration and that the claims and the complete specification must be read as a whole. The Court allowed a method claim to be amended to a product (implant) claim. The Court held that claims have to be read with their specifications.

There is no provision under the Patents Act for re-examining a patent once granted, except that any person interested may approach the Patent Office to file a post-grant opposition or the High Court to file a revocation petition to invalidate the patent.

Patent duration

How is the duration of patent protection determined?

The duration of patent protection is 20 years. It is determined from the date of filing the application. If a provisional application has been filed followed by a complete specification, the term of the patent is counted from the date of filing the provisional application.

In the case of national phase applications under the Patent Cooperation Treaty, the term is calculated from the international filing date. On being granted a patent, the patentee shall have privileges and rights from the date of publication of the application, except in the case of postal applications, where the rights and privileges will accrue from the date of grant of a patent.